PUFFINS Brain Health Study
ConditionCerebral Small Vessel Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorUniversity of Aberdeen
About this trial
Small vessel disease (SVD) is a major cause of stroke and contributor to dementia cases. As work continues to develop new treatments to address the impact of SVD, new imaging techniques are needed to identify and track the progression of brain changes that occur with SVD. Magnetic Resonance Imaging (MRI) is the gold standard to diagnose poor brain health due to small vessel disease. However, current MRI systems are expensive and complex to operate, and so access is limited.
Low-field MRI technology, operating at magnetic field strengths many times lower than conventional MRI, can make brain imaging much more cost-effective and accessible. However, further work is needed to develop low-field MRI towards clinically feasible assessments of brain health. The University of Aberdeen hosts a unique network of researchers and imaging technologies that is now making it possible to test and develop different low-field MRI approaches towards solving key healthcare challenges.
The aim of this study is to evaluate the potential of two distinct approaches, field-cycling imaging (FCI) and ultra-low field MRI (ULF-MRI), to detect brain changes linked with small vessel disease. Automated methods will be developed to analyse images and extract measurements that detect and track progression of disease severity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults ≥ 50 years old.
Subjects who do not report problems with memory.
Small vessel disease (Fazekas score 1 to 3).
Suitable body habitus.
Disqualifiers
History of major stroke (minor stroke/Transient Ischaemic Attacks or lacunar stroke are acceptable).
Individuals unable to give informed consent.
Contra-indications to MRI scanning such as implantable cardiac devices.
Trial population
Participants who small vessel disease, Fazekas score 1 to 3. Study population will be recruited from the NHS Grampian region.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Enrolment 3T MRI research scan
Other interventionEnrolment research scan performed with 3T magnetic resonance imaging scanner.
Enrolment Field-cycling Imaging research scan
Other interventionEnrolment research scan performed with Field-Cycling Imaging scanner.
Enrolment ultra-low field MRI research scan
Other interventionEnrolment research scan performed with ultra-low field MRI scanner
Follow up 3T MRI research scan
Other interventionFollow up research scan performed with 3T magnetic resonance imaging scanner, 18-months after baseline scans.
Follow up Field-cycling Imaging research scan
Other interventionFollow up research scan performed with Field-Cycling Imaging scanner, 18-months after baseline scans.
Follow up ultra-low field MRI research scan
Other interventionFollow up research scan performed with Ultra-low field MRI scanner, 18-months after baseline scans.
Enrolment cognitive assessment interview
Other interventionEnrolment interview performed to complete cognitive assessment scoring of Montreal Cognitive Assessment, EQ-5D, Trail making test, Animal naming test, controlled oral word association test, and Hopkins Verbal Learning Test.
Follow up cognitive assessment interview
Other interventionFollow up interview performed to complete cognitive assessment scoring of Montreal Cognitive Assessment, EQ-5D, Trail making test, Animal naming test, controlled oral word association test, and Hopkins Verbal Learning Test. Performed 18-months after baseline interview.
Treatment groups
85 Participants
are divided into 4 treatment groupsGroup A: Participants with mild small vessel disease (Fazekas score = 1)3 interventions
Group B: Participants with moderate small vessel disease (Fazekas score = 2)3 interventions
Group C: Participants with severe small vessel disease (Fazekas score = 3)3 interventions
Group D: Follow up group. Participants with moderate or severe small vessel disease (Fazekas score = 2 or 3).8 interventions
Trial outcomes
Primary outcomes
1
Small vessel disease volume agreement between enrolment Field-Cycling Imaging and enrolment 3T MRI.
Linear regression analysis will be performed between small vessel disease volume obtained from Field-Cycling Imaging (FCI) and 3T MRI. Sensitivity will be determined as the effect gradient (gradient of the line of best fit between FCI volume and 3T MRI volume). Precision will be determined as coefficient of variation. Agreement will be determined as Dice coefficient.
Time frame
At enrolment2
Small vessel disease volume agreement between follow up Field-Cycling Imaging and follow up 3T MRI.
Linear regression analysis will be performed between small vessel disease volume obtained from Field-Cycling Imaging (FCI) and 3T MRI. Sensitivity will be determined as the effect gradient (gradient of the line of best fit between FCI volume and 3T MRI volume). Precision will be determined as coefficient of variation. Agreement will be determined as Dice coefficient.
Time frame
At 18 month follow upSecondary outcomes
1
Small vessel disease volume agreement between enrolment Field-Cycling Imaging and enrolment Ultra-low Field MRI.
Linear regression analysis will be performed between small vessel disease volume obtained from Field-Cycling Imaging (FCI) and Ultra-low Field MRI. Sensitivity will be determined as the effect gradient (gradient of the line of best fit between FCI volume and Ultra-low Field MRI volume). Precision will be determined as coefficient of variation. Agreement will be determined as Dice coefficient.
Time frame
At enrolment2
Small vessel disease volume agreement between follow up Field-Cycling Imaging and follow up Ultra-low Field MRI.
Linear regression analysis will be performed between small vessel disease volume obtained from Field-Cycling Imaging (FCI) and Ultra-low Field MRI. Sensitivity will be determined as the effect gradient (gradient of the line of best fit between FCI volume and Ultra-low Field MRI volume). Precision will be determined as coefficient of variation. Agreement will be determined as Dice coefficient.
Time frame
At 18 month follow up3
Strength of association between small vessel disease volume obtained from Field-Cycling Imaging, with small vessel disease severity (Fazekas score), age, mood, and cognition.
Linear regression analysis will be performed to assess the strength of associations between small vessel disease volume obtained from Field-Cycling Imaging and small vessel disease severity (Fazekas score), age, mood and cognition derived from the memory, language, and processing speed measures.
Time frame
At enrolment4
Strength of association between small vessel disease volume obtained from Ultra-low Field MRI, with small vessel disease severity (Fazekas score), age, mood, and cognition.
Linear regression analysis will be performed to assess the strength of associations between small vessel disease volume obtained from ultra-low field MRI and small vessel disease severity (Fazekas score), age, mood and cognition derived from the memory, language, and processing speed measures.
Time frame
At 18 month follow upOther outcomes
1
Extent of linear associations between relaxation rate measurements and multiparametric 3T MRI.
General linear model analysis of relaxation rate measurements, apparent diffusion coefficient and transverse relaxation time, magnetitic transfer ratio, chemical exchange saturation transfer tissue pH, will be performed to investigate the linearity of associations. Exploratory factor analysis will be used to reduce number of 3T MRI parameters to hypothesised factors of microstructure integrity, iron concentration, degree of demyelination and tissue pH.
Time frame
At enrolmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aberdeen
Lead sponsor
NHS Grampian
Collaborator
Source ClinicalTrials.gov